Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laser Spectrum, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
191 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863520 | CO2 LASER MICROMANIPULATOR | Laser Spectrum, Inc. | 1986-10-06 | 26 | 0 |
| K844765 | ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN | Laser Spectrum, Inc. | 1985-04-08 | 122 | 0 |
| K841781 | MODEL 305AA PORTABLE LASER | Laser Spectrum, Inc. | 1984-11-07 | 191 | 0 |
| K842498 | DANIELL DBL PUNCTURE LASER LAPAROSCOPY | Laser Spectrum, Inc. | 1984-09-25 | 91 | 0 |
| K841668 | CO2 LAPAROSCOPE | Laser Spectrum, Inc. | 1984-04-23 | 0 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda